Regulatory Compliance
& Standards Overviews

Plastic materials are often specified in food and drug processing, handling,
or packaging equipment. In order for these materials to be used, federal,
state, or association regulatory requirements may have to be met. Requirements
vary from organization to organization, so standards must be checked for
each material, component or equipment configuration.

The following are brief descriptions of regulatory organizations,
requirements, and standards that may apply to stock shape products (sheet,
rod, tube and film) or components made from those materials.

The Food and Drug
Administration (FDA) is the regulatory agency of the United
States government that is responsible for determining how materials may be
used in contact with food products. The FDA participates in publication of
The Federal Register, which contains
The Code of Federal Regulations (CFR), a
codification of the general rules established by the Executive departments
and agencies of the Federal Government. The Code is divided into 50 titles
which represent a broad subject matter.

Definitions for proper use of food contact materials are found in a series of
regulations published annually under The Code of Federal Regulations (CFR)
Title 21.
Title 21 - Food and Drugs
is composed of nine volumes, which are
subdivided into Parts.
Part 177 - Indirect Food Additives: Polymers
lists standards for polymers acceptable for use in components of single and
repeat use food contact surfaces.
Part 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
includes standards for certain polymer additives. Parts are divided into
Sections identified by chemical family which indicate physical, chemical, and
compositional requirements, as well as acceptable service conditions for food
contact. Regulations generally limit the extractable substance when exposed
to selected solvents.

Within the FDA, there is no government-operated process of inspection of
plastics produced for food contact use. Rather, the FDA in their regulations
provides certain specifications regarding composition, additives, and
properties. A material which meets these standards can then be stated as FDA
COMPLIANT. End users should note that it is their responsibility to use the
product in a manner compatible with FDA guidelines.

For further information on FDA regulations, contact the U.S. Food & Drug
Administration, Office of Premarket Approval HFS-216, 200 C. Street SW,
Washington, DC 20204, by phone at (202) 418-3080,
or visit them at
http://www.fda.gov
on the Internet.

The United States Department of Agriculture (USDA)
Food and Safety and Inspection Service
regulates manufacturing, packaging and handling practices
in the agricultural food industry. The USDA has jurisdiction over equipment
used in meat and poultry processing plants. Materials used in this equipment
are approved on an individual basis.

For a product to be USDA COMPLIANT, components used in direct food
contact must be documented as to their compliance with the Federal Food, Drug
and Cosmetic Act ("FDA compliance") by a written letter of guaranty from the
manufacturer to ensure that they are formulated in compliance with
appropriate regulations. Therefore, USDA requirements for material approval
are satisfied by a certification of FDA compliance (see
FDA section above).

For further information on USDA regulations, contact U.S. Department of
Agriculture, Compounds and Packaging Branch, Product Assessment Division,
Building 306 BARC-East, Beltsville, MD 20705. By phone; (301) 504-8566.
or visit them at
http://www.usda.gov
on the Internet.

Agriculture & Agrifood Canada
(Food Production and Inspection Branch) and
Health Canada
(Health Protection Branch) are the Canadian government agency equivalents to
the United States' USDA and FDA, respectively. These Canadian counterparts
both conduct evaluations on material formulations, issuing "no objection
letter(s)" on an application specific basis. Unlike current FDA and USDA
policies, materials cannot be self-certified by manufacturers without prior
Agency review and approval.

3A-Dairy was founded in 1920's by three dairy related associations in the
interest of creating sanitary standards and practices for equipment and
systems used to process milk and milk products, and other perishable foods. Today, the
3-A Sanitary Standards Committees are composed of representatives from many
government agencies and industry.

Standard Number 20-20, 3-A Sanitary Standards for Multiple-Use Plastic
Materials Used as Product Contact Surfaces for Dairy Equipment has been
developed to "_cover the material requirements of plastics for
multiple-use as product contact and/or cleaning solution contact surfaces
in equipment for production, processing and handling of milk and milk
product(s)." Test criteria for approval of plastic materials include
cleanability, bacterial treatment, repeat use conditions, and FDA
compliance. Samples are subjected to chemicals representative of dairy
clearing compounds and measured for weight change and changes in surface
appearance.

To display the 3A-Dairy symbol, equipment manufactures must use only 3A Dairy
approved plastic materials. Using unapproved materials while displaying the 3A symbol
can result in the loss of the right to display the symbol. Many states
including CA and WI (the two largest dairy food suppliers) have incorporated
the 3A standard into their state inspection standards.

The 3A-Dairy organization annually publishes a list of approved plastic materials.
Important Note: Materials are approved by product, grade, form, and supplier,
and not by generic material.

NSF International,
formerly known as the National Sanitation Foundation, is an independent,
not-for-profit, neutral agency that sets standards for all direct and
indirect drinking water additives. Manufacturers who provide equipment
displaying
the NSF
symbol have applied to the NSF for device approval to a specific
standard. The approval is issued for the finished product (device) in a
specific use (application). For example, a commercial ice machine
manufacturer will obtain NSF approval for the ice machine (device to
Standard - application).

To obtain device approval, all components within the device must comply with
the Standard. Establishing compliance of the equipment's components can be
accomplished in one of two ways:

The component has been tested to the Standard by the component supplier
and is certified as such.

The equipment manufacturer must supply documentation that the component
meets the Standard, If any testing is required, it must be completed by
the equipment manufacturer.

The NSF maintains hundreds of Standards, but three standards which apply
to plastic products are:

# 14 - Manufacture of Fittings and for Accessories other than Pipe
Fittings : applies to thermoplastic and thermoset plastics piping
system components in contact with potable water and primarily addresses
physical properties of plastic components in piping and plumbing systems.

For further information on NSF Standards, contact NSF International, 3475
Plymouth Road, P.O. Box 1301140, Ann Arbor, MI 48113-0140,
by phone at (800) 673-7275,
or visit them at
http://www.nsf.org
on the Internet. Standards can also be
ordered on-line.

The
United States
Pharmacopeia (USP) is a voluntary, not-for-profit organization that
promotes the public health by establishing and disseminating officially
recognized standards of quality and authoritative information for the
use of medicines and other health care technologies by health
professionals, patients, and consumers.

USP is responsible for establishing legally recognized product standards for
drugs and other health related articles in the United States. In the 1960's,
methodology and requirements were established for plastic materials used for
pharmaceutical containers and closures, and were subsequently adopted by
medical device manufacturers. USP tests measure biological reactivity of
plastics in contact with mammalian cell cultures (in-vitro) and via
implantation and injection of extractables into laboratory animals (in-vivo).
Plastics are classified into one of six classes, each requiring different
levels of testing. Class VI requires the most extensive testing.

USP does not regulate compliance or certification of plastics tested
according to their published methods. The FDA has adopted some the tests
specified by USP for regulation of medical devices.

The American Society
for Testing and Materials (ASTM) is a not-for-profit organization, which
provides a forum for producer, users, and consumers to establish standards
for materials, products, systems, and services. ASTM standards are developed
voluntarily and used voluntarily. Standards become legally binding only when
a government body references them in regulations, or when they are cited in
a contract. ASTM standards referenced in this Guide pertain to
characteristics of plastic resins prepared for property testing via
injection molding. Property values listed in these Standards are
not always representative of extruded shapes.

For further information on ASTM Standards, contact ASTM, 100 Barr Harbor
Drive, West Conshohocken, PA 19428-2959, by phone at (610) 832-9500,
or visit them at
http://www.astm.org
on the Internet.

Underwriters
Laboratories (UL) is an independent, not-for-profit organization
chartered "to establish, maintain, and operate laboratories for the
investigation of devices, systems, and materials with respect to hazards
affecting life and property." "Listing", the most widely recognized of UL's
services, means that samples of a product have been evaluated, and they
comply with UL Standards. Products tested and recognized by UL are listed in
a Component Directory.
Plastic Materials can be evaluated per the following UL Test Methods: